LEVOFLOXACIN tablet, film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14)

Dostępny od:

Direct RX

INN (International Nazwa):

LEVOFLOXACIN

Skład:

LEVOFLOXACIN ANHYDROUS 500 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Levofloxacin tablets are indicated for the treatment of adults (≥ 18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Culture and Susceptibility Testing Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Mi

Podsumowanie produktu:

16.1 Levofloxacin Tablets Levofloxacin tablets are available as follows: 250 mg are available as terra cotta pink, film-coated, oval-shaped tablets, debossed with “TEVA” on one side and “7291” on the other, in bottles of 50. 500 mg are available as peach-colored, film-coated, oval-shaped tablets, debossed with “TEVA” on one side and “7292” on the other, in bottles of 50. 750 mg are available as white to off-white, film-coated, oval-shaped tablets, debossed with “TEVA” on one side and “7293” on the other, in bottles of 50. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
Direct RX
----------
17 PATIENT COUNSELING
INFORMATION
17.1 Antibacterial Resistance
Antibacterial drugs including levofloxacin should only be used to
treat bacterial infections. They do not
treat viral infections (e.g., the common cold). When levofloxacin is
prescribed to treat a bacterial
infection, patients should be told that although it is common to feel
better early in the course of therapy,
the medication should be taken exactly as directed. Skipping doses or
not completing the full course of
therapy may (1) decrease the effectiveness of the immediate treatment
and (2) increase the likelihood that
bacteria will develop resistance and will not be treatable by
levofloxacin or other antibacterial drugs in
the future.
17.2 Administration With Food, Fluids, and Concomitant Medications
Patients should be informed that levofloxacin tablets may be taken
with or without food. The tablet
should be taken at the same time each day.
Patients should drink fluids liberally while taking levofloxacin to
avoid formation of a highly
concentrated urine and crystal formation in the urine.
Antacids containing magnesium, or aluminum, as well as sucralfate,
metal cations such as iron, and
multivitamin preparations with zinc or didanosine should be taken at
least two hours before or two hours
after oral levofloxacin administration.
17.3 Serious and Potentially Serious Adverse Reactions
Patients should be informed of the following serious adverse reactions
that have been associated with
levofloxacin or other fluoroquinolone use:
•
Tendon Disorders: Patients should contact their healthcare provider if
they experience pain,
swelling, or inflammation of a tendon, or weakness or inability to use
one of their joints; rest and
refrain from exercise; and discontinue levofloxacin treatment. The
risk of severe tendon disorders
with fluoroquinolones is higher in older patients usually over 60
years of age, in patients taking
corticosteroid drugs, and in patients with kidney, heart or lung
tran

Charakterystyka produktu

LEVOFLOXACIN- LEVOFLOXACIN TABLET, FILM COATED
DIRECT RX
----------
LEVOFLOXACIN
BOXED WARNING
FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN, ARE ASSOCIATED WITH AN
INCREASED RISK OF TENDINITIS
AND TENDON RUPTURE IN ALL AGES. THIS RISK IS FURTHER INCREASED IN
OLDER PATIENTS USUALLY OVER
60 YEARS OF AGE, IN PATIENTS TAKING CORTICOSTEROID DRUGS, AND IN
PATIENTS WITH KIDNEY, HEART OR
LUNG TRANSPLANTS [SEE WARNINGS AND PRECAUTIONS (5.1 )].
FLUOROQUINOLONES, INCLUDING LEVOFLOXACIN, MAY EXACERBATE MUSCLE
WEAKNESS IN PERSONSWITH
MYASTHENIA GRAVIS. AVOID LEVOFLOXACININ PATIENTS WITH A KNOWN HISTORY
OF MYASTHENIA GRAVIS
[SEE WARNINGS AND PRECAUTIONS (5.2 )].
1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of levofloxacin
tablets and other antibacterial drugs, levofloxacin tablets should be
used only to treat or prevent
infections that are proven or strongly suspected to be caused by
susceptible bacteria. When culture and
susceptibility information are available, they should be considered in
selecting or modifying
antibacterial therapy. In the absence of such data, local epidemiology
and susceptibility patterns may
contribute to the empiric selection of therapy.
Levofloxacin tablets are indicated for the treatment of adults (≥ 18
years of age) with mild, moderate,
and severe infections caused by susceptible isolates of the designated
microorganisms in the conditions
listed in this section.
CULTURE AND SUSCEPTIBILITY TESTING
Appropriate culture and susceptibility tests should be performed
before treatment in order to isolate and
identify organisms causing the infection and to determine their
susceptibility to levofloxacin [see
Microbiology (12.4)]. Therapy with levofloxacin tablets may be
initiated before results of these tests
are known; once results become available, appropriate therapy should
be selected.
As with other drugs in this class, some isolates of Pseudomonas
aeruginosa may develop resistance
fairly rapidly during treatment with levofloxacin tablets. Cultu